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BioWorld - Saturday, March 21, 2026
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Home » MDIC’s Make CAPA Cool program ringing up success stories
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MDIC’s Make CAPA Cool program ringing up success stories

April 26, 2021
By Mark McCarty
The Medical Device Innovation Consortium (MDIC) has been hard at work on the Make CAPA Cool program in an effort to beef up device makers’ corrective and preventive action (CAPA) programs. Kathryn Merrill, regulatory program director for Dublin-based Medtronic plc, said on an April 26 webinar that participants in the program have shaved CAPA times from 381 days to as few as 63 days, an improvement that industry hopes will ward off warning letters and product quality issues.
Medical technology Regulatory U.S. FDA

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